General Manager of TACIS project of European Commission in CIS, Manager of UNCTAD, WTO, ITC ,
EU, World Bank, UNCTAD/WTO,
trainer of GCP, GLP, GDP,GMP
Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
Gerson
Lehrman healthcare Council, First Clinical Research LLC Speakers
Bureau, former head of consulting Group of the Department of Clinical Research
( 2006-2008 ).
The pharmaceutical industry has the responsibility not only to manufacture effective and safe products, but also to ensure that they are delivered to the patient in a safe and controlled manner. Management of the supply chain is a critical activity which requires adequately designed facilities, documentation systems and trained staff. This training course will cover the regulatory requirements developed by the EU and USA regulators as well as the WHO (World Health Organisation). Delegates attending this course will be provided with information on how to design and manage warehouses, select contractors, temperature map their warehouse, develop temperature monitoring system and manage transportation of their products. In addition guidance will be given on preparing SOPs, documentation and preparing facilities for EU/USA regulatory inspections. Interactive workshops especially designed to enable participant exchange views, share experiences with others and, our expert tutor while being guided through key aspects of pharmaceutical supply chain management.
Course will be of interest to the following industries:
Pharmaceutical/veterinary manufacturers
Biotech manufacturers
Vaccine manufacturers
Suppliers of vaccines
Healthcare providers
Supplier of services to the above industries
Hospital management
Wholesalers
Production managers
Qualified Persons/Responsible Persons
Project Managers
Procurement Managers
Quality Assurance managers/Quality Control Managers
Supplier Auditors
Regulatory Affairs Personnel
Distribution/Transport/Logistics Managers
Professionals from Distribution and Logistics Functions
Contract Warehouse Managers
PROGRAM
Regulatory requirements
EU Directives
WHO Guidelines
EU Legislations on Wholesale Distribution
EU Guidelines for Wholesale Distribution Practice
Role of Qualified Person and Responsible Person
Premises and facilities
Facility design
Cleaning & ‘cleanability’
Security and product integrity
People movement
Materials movement
Product segregation
Control of contamination/cross contamination
Temperature control & Monitoring – what is required
Personnel
Staff selection and qualification
GDP/GMP training
SOP Training
Training records
Quality Systems
Documentation
Definitions Orders
Procedures
Records
Document control and maintenance
Document Archiving
Preparing training packages
Procedures
Identifying what is required
how to develop a standard format and structure
writing SOPs
critical SOPs for a warehouse
preparing SOP training packages
Non Compliance Management
investigation of non-compliance
reporting and documentation
corrective action and preventive action planning (CAPA)
Returns Management
returns of non-defective medicinal products
security and QA decision
Emergency Planning and Recall
recall procedure
investigation and reporting
corrective action planning
Sampling
facility requirement
control of product and facility contamination
documentation
Stock Management
cycle counting
Packaging & Re-labelling
facility and equipment requirements
SOPs and Documentation
staff training
Warehouse Management System
Developing specification
Vendor selection
Validation
Self Inspection
regulatory expectations
checklists
reporting and action planning
Contractors
Decision process for outsourcing
Contractor selection process
Quality/Technical agreement
Contract considerations
Audits of contractors
Transportation
Modes of transportation and challenges they offer Air
Land
sea
Vehicle design consideration
Security issues
Temperature monitoring & control
Non compliance reporting and action planning
Cold Chain Management
Developing specification
Facility design consideration
Transport issues
Packaging options
Monitoring during storage and transport
Developing procedures
Training and control
Dealing with out of specification situations
Temperature Mapping
What to consider when mapping your warehouse/trailer
Design considerations
Developing plans
Test protocols
Identifying the risk areas
Planting the temperature monitors
Collating data and data evaluation
Reporting – developing recommendations
How to maintain the qualified status -On going maintenance
Preparing for Inspections
Developing self inspection programme
Training issues
Internal audits
Action planning Root cause analysis
Preventive action
Maintaining inspection readiness status
Inspection findings
Most recent regulatory and client inspection findings
Our Partners:
Sheraton Hotel Montazah
1) Quality of our services confirmed by audits.
2) International level of GCP / GMP / ISO trainers and auditors.
3) You can check at any time any GCP / GMP / ISO certificate for authenticity.
06 July 2014
Current GDP Audit - contract research organization (CRO)
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